PAID study design on the role of PKC activation in immune/inflammation-related depression:a randomised placebo-controlled trial protocol

作     者：Xiaoyun Guo Ruizhi Mao Lvchun Cui Fan Wang Rubai Zhou Yun Wang Jia Huang Yuncheng Zhu Yamin Yao Guoqing Zhao Zezhi Li Jun Chen Jinhui Wang Yiru Fang Xiaoyun Guo;Ruizhi Mao;Lvchun Cui;Fan Wang;Rubai Zhou;Yun Wang;Jia Huang;Yuncheng Zhu;Yamin Yao;Guoqing Zhao;Zezhi Li;Jun Chen;Jinhui Wang;Yiru Fang

作者机构：Department of PsychiatryShanghai Mental Health CenterShanghai Jiao Tong University School of MedicineShanghaiChina Department of PsychologyShandong Provincial Hospital affiliated to Shandong First Medical UniversityJinanShandongChina Department of NeurologyRenji HospitalShanghai Jiao Tong University School of MedicineShanghaiChina Clinical Research Center and Division of Mood DisordersShanghai Mental Health CenterShanghai Jiao Tong University School of MedicineShanghaiChina College of Life SciencesChinese Academy of SciencesBeijingChina CAS Center for Excellence in Brain Science and Intelligence TechnologyChinese Academy of ScienceShanghaiChina Shanghai Key Laboratory of Psychotic DisordersShanghaiChina 

出 版 物：《General Psychiatry》 (综合精神医学（英文）)

年 卷 期：2021年第34卷第2期

页      面：104-110页

核心收录：

学科分类：1002[医学-临床医学] 100205[医学-精神病与精神卫生学] 10[医学] 

基　　金：This work was supported by the National Key R&D Program of China(2016YFC1307100) the National Natural Science Foundation of China(81930033,81771465,81201057) the Shanghai Key Project of Science&Technology(2018SHZDZX05) the National Key Technologies R&D Program of China(2012BAI01B04) the Innovative Research Team of High-level Local Universities in Shanghai 

主　　题：placebo inflammation vitamin 

摘      要：Background Inflammation that is mediated by microglia activation plays an important role in the pathogenesis of *** activation can lead to an increase in the levels of proinflammatory cytokines,including TNF-α,which leads to neuronal apoptosis in the specific neural circuits of some brain regions,abnormal cognition and treatment-resistant depression(TRD).Protein kinase C(PKC)is a key regulator of the microglia activation *** assume that the abnormality in PKC might result in abnormal microglia activation,neuronal apoptosis,significant changes in emotional and cognitive neural circuits,and *** the current study,we plan to target at the PKC signal pathway to improve the TRD treatment *** and analysis This is a 12-week,ongoing,randomised,placebo-controlled *** with TRD(N=180)were recruited from Shanghai Mental Health Center,Shanghai Jiao Tong *** control volunteers(N=60)were recruited by *** with TRD were randomly assigned to‘escitalopram+golimumab(TNF-αinhibitor)’,‘escitalopram+calcium tablet+vitamin D(PKC activator)’or‘escitalopram+placebo’*** define the primary outcome as changes in the 17-item Hamilton Depression Rating Scale(HAMD-17).The secondary outcome is defined as changes in anti-inflammatory effects,cognitive function and quality of *** This study might be the first randomised,placebo-controlled trial to target at the PKC signal pathway in patients with *** study might help to propose individualised treatment strategies for *** registration number The trial protocol is registered with *** under protocol ID 81930033 and *** ID NCT04156425.